To learn more about how your data is used by us when you use the website, please read our Privacy Policy. We use cookies to deliver our services and to ensure that we give you the best experience on our website. For details on our use of cookies, please go to the Cookie Policy

Paris, France – June 22, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today that the first phase 3 study results (EDITION I) for its
investigational new insulin U300 showed equivalent blood sugar control with
fewer night-time low blood sugar events compared to Lantus® (insulin
glargine [rDNA origin] injection). The company also announced topline results of
a second Phase 3 study (EDITION II) for new insulin U300 that also demonstrated
similar blood sugar reduction while fewer patients experienced night-time low
blood sugar events compared with Lantus®.

These results are
from EDITION I and EDITION II respectively and are part of the EDITION Phase 3 clinical
program evaluating the efficacy and safety of the investigational new insulin U300
in people with diabetes. The EDITION I data was presented at the 73rd
Scientific Sessions of the American Diabetes Association.

“To
properly manage diabetes, it is critical to control blood sugar and to reduce
the risk of low blood sugar events, especially at night,” said Matthew
Riddle, Professor of Medicine, Division of Endocrinology/Diabetes/Clinical
Nutrition, Oregon Health and Science University, U.S., and Principal
Investigator for the EDITION I study. “I
am encouraged by these findings, and look forward to the results of the full Phase
3 EDITION program, which will further reveal how this investigational basal
insulin may help people living with diabetes.”

EDITION I

As the first study of
the EDITION Phase 3 program, EDITION I evaluated the efficacy and safety of investigational new insulin U300, vs. Lantus®
in people with type 2 diabetes using basal plus mealtime insulin. In a
multicenter, open-label study 807 people were randomized (1:1) to once daily
evening new insulin U300 (n=404) or Lantus®
(n=403) while continuing mealtime insulin. The basal insulin was titrated to
achieve fasting plasma glucose of 80-100 mg/dL. Primary endpoint was change in
HbA1c from baseline to month 6, and main secondary endpoint was % of
people with at least 1 severe or confirmed (≤70 mg/dL) nocturnal hypoglycemic
event from month 3 to month 6.

The investigational new insulin
U300 was associated with a 21% reduction in severe
or confirmed nocturnal hypoglycemia (low blood sugar) from month 3 to month 6. Significantly
fewer patients had nocturnal (severe and/or confirmed; i.e. ≤70 mg/mL)
hypoglycemia (low blood sugar) during months 3 to 6 (pre-specified main
secondary endpoint: 36.1% vs. 46.0%; RR 0.79; p=0.0045) and the occurrence of
any nocturnal hypoglycemic event (% of people with at least one event) during
the 6-month study period was lower on new insulin U300 during the study period compared
to the Lantus® group (45.3% vs. 59.7%; RR 0.76; 95% CI 0.66 to 0.87). New insulin U300 was well-tolerated in this study, with no differences
in other adverse events observed from Lantus®.

The EDITION I abstract is titled: New Insulin Glargine Formulation: Glucose Control and
Hypoglycemia in People with Type 2 Diabetes Using Basal and Mealtime Insulin
(EDITION I) (Riddle, MC et al) [Abstract no. 43-LB]

EDITION II evaluated efficacy and safety of new
insulin U300 in
a type 2 diabetes population (811 patients) treated with basal insulin plus
oral antidiabetic therapy. The full EDITION II results will be submitted for presentation at
upcoming scientific
meetings.

“There remains a
substantial unmet need in people with diabetes taking oral medication or
insulin as many of them do not reach their glycemic goals,” said Pierre Chancel,
Senior Vice President, Global Diabetes, Sanofi. “With the investigational new insulin U300, we are striving to further
enhance the clinical value of basal insulin, while building on the wealth of
evidence of Lantus®, the world’s most prescribed insulin.”

About investigational new insulin U300

Investigational new insulin U300 is a new formulation based on the
glargine molecule, the biological entity of Lantus®, with its well
established efficacy and safety profile. However, new insulin U300 has unique
pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has
even flatter and more prolonged profiles than Lantus®.1,2 New insulin U300 also offers the benefit of a smaller
volume of subcutaneous injection compared with Lantus®.

About the EDITION Phase 3 Program

The EDITION program is a worldwide and
comprehensive series of Phase 3 studies evaluating the efficacy and safety of new insulin
U300 in broader and diverse populations of people
with diabetes. The full EDITION I (basal + mealtime insulin) and EDITION II
(basal Insulin + oral therapy) results are expected by the end of this year. Additionally,
the following Phase 3 studies from the EDITION program are ongoing: EDITION III
in insulin-naïve type 2 diabetes patients , EDITION IV in type 1 diabetes
patients, EDITION JP I in Japanese type 1 diabetes patients (basal + bolus
insulin) and EDITION JP II in Japanese type 2 diabetes patients (basal insulin
+ oral therapy).

About Diabetes

Diabetes
is a chronic disease that occurs as type 1 diabetes, which is an autoimmune
disease characterized by the lack of insulin (the hormone that regulates blood
glucose concentrations) production by the pancreas, and type 2, a metabolic
disorder in which there are two main biological defects: a deficient production
of insulin and reduced ability of the body to respond to the insulin being
produced. Type 1 and type 2 diabetes are characterized by an increase in blood
glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia
leads to the macrovascular and microvascular complications of diabetes.
Macrovascular complications, which affect the large blood vessels, include
heart attack, stroke and peripheral vascular disease. Microvascular
complications affect the small blood vessels of the eyes (retinopathy), kidney
(nephropathy) and nerves (neuropathy). The global incidence of diabetes is
growing at an alarming rate, with more than 371 million people worldwide living
with the condition today.

About Sanofi Diabetes

Sanofi strives to help people manage the
complex challenge of diabetes by delivering innovative, integrated and
personalized solutions. Driven by valuable insights that come from listening to
and engaging with people living with diabetes, the Company is forming
partnerships to offer diagnostics, therapies, services and devices, including
blood glucose monitoring systems. Sanofi markets both injectable and oral
medications for people with type 1 or type 2 diabetes.

About
Sanofi

Sanofi,
an integrated global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients’ needs. Sanofi has core strengths in
the field of healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets, animal
health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).

This press
release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include projections and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with respect to future
financial results, events, operations, services, product development and
potential, and statements regarding future performance. Forward-looking
statements are generally identified by the words “expects”, “anticipates”,
“believes”, “intends”, “estimates”, “plans” and similar expressions. Although
Sanofi’s management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally beyond the
control of Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA, regarding
whether and when to approve any drug, device or biological application that may
be filed for any such product candidates as well as their decisions regarding
labelling and other matters that could affect the availability or commercial
potential of such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future approval and
commercial success of therapeutic alternatives, the Group’s ability to benefit
from external growth opportunities, trends in exchange rates and prevailing
interest rates, the impact of cost containment policies and subsequent changes
thereto, the average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by Sanofi,
including those listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year
ended December 31, 2012. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any forward-looking
information or statements.

Sanofi
will host a conference call for the financial community on Monday June 24,
2013, at 700 AM CST (200 PM Paris Time). The call will include results from the
ongoing EDITION phase 3 program for U300 as well as a status update on the
fixed-ratio combination of insulin glargine and lixisenatide.

Dial-in
numbers and the audio webcast link will be accessible via www.sanofi.com.